Study information

Scientific title

Acronym

FKC

Study hypothesis

There will be a difference in pain response, time to recovery and heart rate variability (HRV) from heel lance in 28 - 36 weeks gestational age Neonatal Intensive Care Unit (NICU) preterm neonates when they are engaged in maternal kangaroo care (KC) compared to when they are engaged in father's KC.

Ethics approval

CHU St-Justine Research Ethics Board (REB) gave approval on the 16th July 2007 (ref: 2580)

Study design

Randomised controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pain response during heel lancing

Intervention

After obtained informed consent from the mother and the father, the neonate will be randomised to intervention (father first mother second) or control (mother first father second). Kangaroo care involves placing a diaper-clad neonate at an angle of sixty degrees between the breasts or on the chest providing maximal skin-to-skin contact between the infant and the caregiver. The neonate is placed in KC 15 minutes before the painful procedure (heel lance) performed by a hospital technician assigned to the study. The heel lance procedure is relatively standardised across staff and timing and is an aspect of routine care for hospitalised preterm neonates. Each neonate will have two KC sessions filmed; one with the mother and the other one with the father. The measures will be taken for the entire heel lance procedure (one minute of baseline isolette, one minute of baseline kangaroo, one minute of warming, extraction of the blood and return to baseline kangaroo and isolette.

Secondary outcome measures

Timing for return to physiologic baseline measured as the preterm neonate's return to baseline HR after the heel lance procedure procured via an oximeter placed on the unaffected foot of the neonate.

Overall trial start date

01/10/2007

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Born between 28 0/7 and 35 6/7 weeks of gestation, either sex2. Obtained consent3. Receiving at least two heel lances prior to discharge4. Within 10 days of hospitalisation5. Stable according to Neonatal Intensive Care Unit criteria

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Genetic or major congenital disorders2. Requiring surgery before or during the study period3. Receiving analgesics or paralysing agents4. Intra-ventricular haemorrhage (IVH) grade III+ or periventricular leukomalacia (PVL) as confirmed by ultrasound